Identity
- Trade Name
- 8 mm, 10 mm, 12 mm cartridge (Optional) EUDAMED
- Device Name
- Long-pulsed Nd:YAG Laser EUDAMED
- Model / Reference
- DermaV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800291820286 EUDAMED
- Basic UDI-DI
- 88002918210116AH8 EUDAMED
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
8 mm, 10 mm, 12 mm cartridge (Optional) by Cynosure Lutronic Technology Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88002918210116AH8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Cynosure Lutronic Technology Corporation
- EUDAMED SRN
- KR-MF-000047499
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED fdac8a9c-e4c1-4b3d-9a2a-e4710ba8c631 61 fields · synced Jul 9, 2026